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A pilot randomized, controlled trial comparing Birthly, (an online platform for live group prenatal classes taught by childbirth educators, nurses, and lactation consultants) plus standard prenatal care versus standard prenatal care alone among women with high risk pregnancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Birthly plus standard of care | Active Comparator | Women will receive a code to sign up for childbirth education classes through the Birthly platform. They will also participate in childbirth education at their own discretion. |
|
| Standard of Care | Placebo Comparator | Women will not receive a code for the 3 Birthly courses. They will participate in childbirth education at their own discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Birthly | Other | Women will receive a code to sign up for 3 free interactive childbirth education classes through the Birthly platform. They will be enrolled in 3 courses: Prenatal Education, Childcare and Breastfeeding. They will be encouraged to complete all courses prior to 36 weeks gestational age. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PrAS score | To determine if access to an online comprehensive platform for prenatal education and childbirth courses decreases pregnancy anxiety as measured by the Pregnancy-Related Anxiety Scale (PrAS) in nulliparous women with high risk pregnancies compared to usual prenatal care. The primary study endpoint will be a 15% reduction in PrAS score from 64 to 55 with a SD of 15.22. | time of enrollment to 34-40 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in healthcare utilization | Measured by the number of unscheduled visits to the obstetrical triage unit or ED, urgent office visits, and triage telephone encounters during pregnancy and in the 6-week postpartum period | time of enrollment through 6-week postpartum |
| Difference in Edinburgh Postnatal Depression Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37054807 | Derived | Zafman KB, Riegel ML, Levine LD, Hamm RF. An interactive childbirth education platform to improve pregnancy-related anxiety: a randomized trial. Am J Obstet Gynecol. 2023 Jul;229(1):67.e1-67.e9. doi: 10.1016/j.ajog.2023.04.007. Epub 2023 Apr 11. |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of care | Other | Subjects will participate in childbirth education at their own discretion. |
|
The scoring scale is 1 to 30, with a higher score indicating a worse outcome |
| one-time score at 4-6 weeks postpartum |
| Difference in intention to breastfeed | Intention to breastfeed prior to delivery | at 34 to 40 weeks gestational age |
| Difference in breastfeeding rates at discharge after delivery | time of discharge from hospital after delivery |
| Difference in breastfeeding rates postpartum | 4-6 weeks postpartum |
| Difference in contraceptive uptake at discharge from hospital | at time of discharge from hospital after delivery, on average 1-3 days postpartum |
| Difference in contraceptive uptake postpartum | 4-6 weeks postpartum |
| Mode of delivery | delivery |
| Number of participants with hypertensive disorders of pregnancy | delivery through 4-6 weeks postpartum |
| Number of participants with maternal readmission | delivery through 4-6 weeks postpartum |
| Number of participants who have Preterm birth | Time of delivery |
| Difference in APGAR scores | Time of birth |
| Number of infants with a need for neonatal respiratory support outside the delivery room | Time of birth |
| Number of infants with a NICU admission | Time of birth |